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Director, Oncology MD Medical Monitor - Full-time / Part-time
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | Cambridge, Massachusetts |
About this job
Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
Role Description
* Applies medical and clinical development knowledge to transform clinical research ideas into high quality clinical recommendations.
* Takes the principal role in helping maintain patient safety across all of the program clinical studies by looking for patterns in the emerging clinical data, and diligently follows up potential safety signals.
* Helps to prepare high-quality responses to questions from health regulatory authorities.
* Works closely with the established network of study thought leaders and principal investigators to ensure smooth operation of clinical studies, and helps with the evaluation of investigator-initiated research study and clinical research collaboration proposals, and study drug requests for research purposes
* In collaboration with individual study clinicians and the alliance partner, executes the development of the clinical strategy for studies and projects with a focus on and attention to medical and scientific details, innovative study design, alignment with the competitive landscape, medical execution, and interpretation.
* In collaboration with individual study clinicians, assesses eligibility of patients for one or more studies, and evaluates potential protocol deviations.
* Conducts clinical reviews and deep dives where necessary into study data (including safety, tolerability, efficacy, overall consistency, and finalization of CAPAs) in collaboration with individual study clinicians.
Responsibilities
Major Duties for Allocated Asset (Fundamental Components of Role)
General
Program-Related:
* Leads or assists in the preparations of the clinical content of regulatory submissions/documents (e.g., NDA, MAA, IND, sNDA, IB, AR/DSRU, CDS, PI)
* Assists in discussions with regulators and leads or contributes to health authority (HA) query response writing, review, and resolution.
* Provides clinical input into the preparation and execution of meetings with HAs.
* Works with Global Clinical Lead and (Asset) Team Lead to ensure that the assigned studies fulfill their role in the overall Clinical Development Plan.
* Maintains and enhances knowledge in relevant therapeutic or technical areas and in global regulations/guidelines.
* Provides Clinical/Medical input to other departments (e.g., WRD, Medical Affairs, Commercial) to support asset development as well as marketing and product enhancement/ differentiations efforts as needed.
* May organize expert panel, consultant or advisory board meetings to provide input to clinical development plans.
* Help prepare slide presentations for internal governance committee meetings, investigator meetings, site initiation visits, scientific symposia, etc.
* May be an active member of an alliance partnership team.
* May present to senior management, governance committees, and external audiences on the clinical aspects of asset development, including milestones, strategies, and clinical trial data, as appropriate.
* Represents the Clinical line on project-related teams and cross-divisional committees (e.g., TRC, PQRC)
* Reviews IIR proposals upon special request based on subject matter expertise.
* Interfaces with other Pfizer sites, other TAs, and other functions to share best practices, as appropriate
* Early Development clinical studies only) Responsible for the Safety Surveillance and Risk Management (SSRM) component of the Asset Development Plan until achievement of POC, in agreement with SOP SAF09 and in collaboration with the SRL.
People-Related:
* Motivates and engages colleagues to understand a disease, and communicates commitment and excitement about an indication and/or mechanism of action.
* May coach and mentor less experienced Medical Monitors, Study Clinicians, and Clinical Study Subteam Members.
* May manage direct reports, including performance management and career development (recruiting, retaining and developing top talent)
Therapeutic Area
* Independently maintains state of the art knowledge in the therapeutic area.
* With line management endorsement, manages and initiates external collaborations to develop new methodologies and to investigate mechanisms relevant to the therapeutic area.
Study Planning and Facilitation
* Creates or supports study protocol creation from outline to final protocol in collaboration with a Study Clinician and the GCL.
* Contributes to study outlines and provides medical expertise to development of clinical protocols.
* Promotes novel approaches in study designs and through application of enhanced clinical trial design, ensuring the most efficient clinical protocols are developed.
* Reviews the Informed Consent Document (ICD) template in collaboration with the study clinician
* Reviews and approves the risk section of the Informed Consent Document (ICD) template.
* Provides clinical input to study teams on CRF design, statistical analysis plan, monitoring guidelines, Data Review Plan, and IQMP as needed.
* Reviews and addresses significant protocol deviations (PD), PD trends and Quality Qualifying Issues
* Supports other lines (e.g., Development Operations) to ensure that the budget fits within the overall development plan in collaboration with individual study clinicians.
* Works with Development Operations and/or the AP and RMMs/RMRSs to identify, evaluate, and select clinical sites and investigators with appropriate qualifications, patient populations, and recruitment strategy to meet goals in a time- and cost-effective manner.
* Liaises with IOBU-SDMC, E-DMC, and Steering Committee as required by the protocol.
* May lead or oversee compassionate-use programs.
Study Conduct and Monitoring
* Ensures adherence to Safety Review Plan (SRP).
* May perform and document the regular review of individual subject safety data. The specific components of safety data review are detailed in the Safety Data Review Guide -- for Clinicians, and in SOP SAF09.
* Regularly reviews and tracks emerging safety, tolerability, and efficacy profile of the drug.
* Must be fully knowledgeable about the safety profile of allocated drugs on which studies are being conducted, or which are called for in the protocol.
* May serve as principal contact on scientific and medical issues for Development Operations, study managers/monitors, external collaborators, and study sites during the conduct of the clinical trial.
* Leads contact with PIs about safety issues Supports protocol amendments, as necessary, to address safety, efficacy or operational issues.
* May be responsible for the clinical section of the Trial Master File.
Study Analysis and Reporting
* Works with biometrics and other clinical staff (e.g., Clinical Pharmacology) in the review and the interpretation of data in collaboration with individual study clinicians.
* Is responsible for the medical and scientific validity of the clinical study report, especially conclusions regarding efficacy and safety.
* May co-author abstracts, posters, presentations, and publications.
Qualifications
Training and Education
Required:
* MD with minimum of 3+ years of clinical experience.
* Postgraduate training/certification/fellowship in Hematology.
* Prior industry Hematology or Oncology clinical development or equivalent experience.
* Demonstrated technical, administrative, and project management capabilities, as well as effective verbal and written communication skills plus ability to relate well to colleagues and associates both inside and outside of the company.
Preferred:
* Demonstrated scientific productivity (e.g., publications, research reports, etc.).
* Thorough understanding of local and international regulations applicable to clinical development.
* Practical experience in clinical trial strategies, methods, and processes.
* Track record of designing and interpreting excellent focused development plans and clinical studies.
* Experience with regulatory submissions.
Technical Competencies-Specific Skills
* Potential or ability to design, initiate, and conduct clinical studies
* Demonstrated technical, administrative, and project management capabilities, as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the corporation
* Ability to review and understand the emerging safety and efficacy profile of the drug candidate; part of this skill is putting the profile in perspective with comparator agents
* Demonstrated understanding of the complexities and recent developments in the relevant therapeutic/technical area, and the ability to apply such knowledge to drug development
* Demonstrated ability to present clinical data, study plans and tactics clearly and accurately to relevant audiences in order to enhance decision making
Behavioral Competencies-Specific Skills
Being able to learn and demonstrate through every day actions the set of cultural traits and behaviors identified as critical for the OBU:
Engaging:
* Collaborating -- routinely seeking input and feedback from others
* Listening and valuing our colleagues, actively engaging across function and culture
* Thinking inclusively
* Providing clear and effective decision rules empowering individuals to make decisions and execute solutions
Trust-Based:
* Respecting each other's styles, needs, and values
* Trusting and committing to support each other and succeed together
* Engaging in productive conflict to find the best solution together
Resilience:
* Persevering -- Working together to overcome challenges and deliver results
* Demonstrating adaptability in order to achieve the ultimate goal
* Keeping customers and cancer patients front and center
Ownership:
* Striving to deliver results -- smarter, better, faster
* Meeting goals/aiming for stretch goals
* Having a sense of urgency & action-orientation
* Taking calculated risks to drive innovation
* Constantly working to eliminate barriers
* Finding the positive way forward
Oncology Expertise:
* Understanding the needs of customers and cancer patients better than any other company
* Owning the spaces that we have molecules in growing expertise in current and emerging science that translates to patient benefit
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
Role Description
* Applies medical and clinical development knowledge to transform clinical research ideas into high quality clinical recommendations.
* Takes the principal role in helping maintain patient safety across all of the program clinical studies by looking for patterns in the emerging clinical data, and diligently follows up potential safety signals.
* Helps to prepare high-quality responses to questions from health regulatory authorities.
* Works closely with the established network of study thought leaders and principal investigators to ensure smooth operation of clinical studies, and helps with the evaluation of investigator-initiated research study and clinical research collaboration proposals, and study drug requests for research purposes
* In collaboration with individual study clinicians and the alliance partner, executes the development of the clinical strategy for studies and projects with a focus on and attention to medical and scientific details, innovative study design, alignment with the competitive landscape, medical execution, and interpretation.
* In collaboration with individual study clinicians, assesses eligibility of patients for one or more studies, and evaluates potential protocol deviations.
* Conducts clinical reviews and deep dives where necessary into study data (including safety, tolerability, efficacy, overall consistency, and finalization of CAPAs) in collaboration with individual study clinicians.
Responsibilities
Major Duties for Allocated Asset (Fundamental Components of Role)
General
Program-Related:
* Leads or assists in the preparations of the clinical content of regulatory submissions/documents (e.g., NDA, MAA, IND, sNDA, IB, AR/DSRU, CDS, PI)
* Assists in discussions with regulators and leads or contributes to health authority (HA) query response writing, review, and resolution.
* Provides clinical input into the preparation and execution of meetings with HAs.
* Works with Global Clinical Lead and (Asset) Team Lead to ensure that the assigned studies fulfill their role in the overall Clinical Development Plan.
* Maintains and enhances knowledge in relevant therapeutic or technical areas and in global regulations/guidelines.
* Provides Clinical/Medical input to other departments (e.g., WRD, Medical Affairs, Commercial) to support asset development as well as marketing and product enhancement/ differentiations efforts as needed.
* May organize expert panel, consultant or advisory board meetings to provide input to clinical development plans.
* Help prepare slide presentations for internal governance committee meetings, investigator meetings, site initiation visits, scientific symposia, etc.
* May be an active member of an alliance partnership team.
* May present to senior management, governance committees, and external audiences on the clinical aspects of asset development, including milestones, strategies, and clinical trial data, as appropriate.
* Represents the Clinical line on project-related teams and cross-divisional committees (e.g., TRC, PQRC)
* Reviews IIR proposals upon special request based on subject matter expertise.
* Interfaces with other Pfizer sites, other TAs, and other functions to share best practices, as appropriate
* Early Development clinical studies only) Responsible for the Safety Surveillance and Risk Management (SSRM) component of the Asset Development Plan until achievement of POC, in agreement with SOP SAF09 and in collaboration with the SRL.
People-Related:
* Motivates and engages colleagues to understand a disease, and communicates commitment and excitement about an indication and/or mechanism of action.
* May coach and mentor less experienced Medical Monitors, Study Clinicians, and Clinical Study Subteam Members.
* May manage direct reports, including performance management and career development (recruiting, retaining and developing top talent)
Therapeutic Area
* Independently maintains state of the art knowledge in the therapeutic area.
* With line management endorsement, manages and initiates external collaborations to develop new methodologies and to investigate mechanisms relevant to the therapeutic area.
Study Planning and Facilitation
* Creates or supports study protocol creation from outline to final protocol in collaboration with a Study Clinician and the GCL.
* Contributes to study outlines and provides medical expertise to development of clinical protocols.
* Promotes novel approaches in study designs and through application of enhanced clinical trial design, ensuring the most efficient clinical protocols are developed.
* Reviews the Informed Consent Document (ICD) template in collaboration with the study clinician
* Reviews and approves the risk section of the Informed Consent Document (ICD) template.
* Provides clinical input to study teams on CRF design, statistical analysis plan, monitoring guidelines, Data Review Plan, and IQMP as needed.
* Reviews and addresses significant protocol deviations (PD), PD trends and Quality Qualifying Issues
* Supports other lines (e.g., Development Operations) to ensure that the budget fits within the overall development plan in collaboration with individual study clinicians.
* Works with Development Operations and/or the AP and RMMs/RMRSs to identify, evaluate, and select clinical sites and investigators with appropriate qualifications, patient populations, and recruitment strategy to meet goals in a time- and cost-effective manner.
* Liaises with IOBU-SDMC, E-DMC, and Steering Committee as required by the protocol.
* May lead or oversee compassionate-use programs.
Study Conduct and Monitoring
* Ensures adherence to Safety Review Plan (SRP).
* May perform and document the regular review of individual subject safety data. The specific components of safety data review are detailed in the Safety Data Review Guide -- for Clinicians, and in SOP SAF09.
* Regularly reviews and tracks emerging safety, tolerability, and efficacy profile of the drug.
* Must be fully knowledgeable about the safety profile of allocated drugs on which studies are being conducted, or which are called for in the protocol.
* May serve as principal contact on scientific and medical issues for Development Operations, study managers/monitors, external collaborators, and study sites during the conduct of the clinical trial.
* Leads contact with PIs about safety issues Supports protocol amendments, as necessary, to address safety, efficacy or operational issues.
* May be responsible for the clinical section of the Trial Master File.
Study Analysis and Reporting
* Works with biometrics and other clinical staff (e.g., Clinical Pharmacology) in the review and the interpretation of data in collaboration with individual study clinicians.
* Is responsible for the medical and scientific validity of the clinical study report, especially conclusions regarding efficacy and safety.
* May co-author abstracts, posters, presentations, and publications.
Qualifications
Training and Education
Required:
* MD with minimum of 3+ years of clinical experience.
* Postgraduate training/certification/fellowship in Hematology.
* Prior industry Hematology or Oncology clinical development or equivalent experience.
* Demonstrated technical, administrative, and project management capabilities, as well as effective verbal and written communication skills plus ability to relate well to colleagues and associates both inside and outside of the company.
Preferred:
* Demonstrated scientific productivity (e.g., publications, research reports, etc.).
* Thorough understanding of local and international regulations applicable to clinical development.
* Practical experience in clinical trial strategies, methods, and processes.
* Track record of designing and interpreting excellent focused development plans and clinical studies.
* Experience with regulatory submissions.
Technical Competencies-Specific Skills
* Potential or ability to design, initiate, and conduct clinical studies
* Demonstrated technical, administrative, and project management capabilities, as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the corporation
* Ability to review and understand the emerging safety and efficacy profile of the drug candidate; part of this skill is putting the profile in perspective with comparator agents
* Demonstrated understanding of the complexities and recent developments in the relevant therapeutic/technical area, and the ability to apply such knowledge to drug development
* Demonstrated ability to present clinical data, study plans and tactics clearly and accurately to relevant audiences in order to enhance decision making
Behavioral Competencies-Specific Skills
Being able to learn and demonstrate through every day actions the set of cultural traits and behaviors identified as critical for the OBU:
Engaging:
* Collaborating -- routinely seeking input and feedback from others
* Listening and valuing our colleagues, actively engaging across function and culture
* Thinking inclusively
* Providing clear and effective decision rules empowering individuals to make decisions and execute solutions
Trust-Based:
* Respecting each other's styles, needs, and values
* Trusting and committing to support each other and succeed together
* Engaging in productive conflict to find the best solution together
Resilience:
* Persevering -- Working together to overcome challenges and deliver results
* Demonstrating adaptability in order to achieve the ultimate goal
* Keeping customers and cancer patients front and center
Ownership:
* Striving to deliver results -- smarter, better, faster
* Meeting goals/aiming for stretch goals
* Having a sense of urgency & action-orientation
* Taking calculated risks to drive innovation
* Constantly working to eliminate barriers
* Finding the positive way forward
Oncology Expertise:
* Understanding the needs of customers and cancer patients better than any other company
* Owning the spaces that we have molecules in growing expertise in current and emerging science that translates to patient benefit
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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